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HealthyPhase 1NCT06106009

A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults

A Phase 1 study testing PF-07976016 and Midazolam in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to learn if the study medicine (called PF-07976016) is safe and how it goes in and out of the body in healthy people. The study may also explore if PF-07976016 has the potential to interact with another medicine called midazolam. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07976016 and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
1 siteUnited States
Study dates
27 Oct 2023to 19 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • A total body weight >50 kg (110 lb).
  • Parts A, B and C only: BMI of 20-33 kg/m2.
  • Part D only: BMI of 30-40 kg/m2 and may have well controlled hyperlipidemia or hypertension.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, skin or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption.
  • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Renal impairment as defined by an estimated glomerular filtration rate of <75 mL/min/1.73 m².
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
Show all 11Show fewer
  • alanine aminotransferase, aspartate aminotransferase, or bilirubin ≥1.05 × upper limit of normal;
  • fasting plasma glucose > 126 mg/dL;
  • HbA1c ≥6.0% (Parts A,B and C); HbA1c ≥6.5% (Part D);
  • hematuria as defined by ≥1+ heme on urine dipstick;
  • albuminuria as defined by urine albumin/creatinine ratio >30 mg/g.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer Clinical Research Unit - New Haven

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Multi-Part, Phase 1 Study With Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single- And Multiple-Dose Escalation To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-07976016 In Healthy Adult Participants

The purpose of this clinical trial is to learn if the study medicine (called PF-07976016) is safe and how it goes in and out of the body in healthy people. The study may also explore if PF-07976016 has the potential to interact with another medicine called midazolam. In addition, the study may explore how PF-07976016 goes into the body of people who have obesity.

Conditions
Healthy
Being tested
PF-07976016, Placebo, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07976016Drug

    Oral solution, oral suspension or solid oral formulation(s)

  • PlaceboDrug

    Oral solution, oral suspension or solid oral formulation(s)

  • MidazolamDrug

    Midazolam oral solution

Study groups in NCT06106009
Study groupRoleWhat they receive
Part A Cohort 1ExperimentalSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part A Cohort 2ExperimentalSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part A Optional Cohort 3ExperimentalSingle dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part A Optional Cohort 4ExperimentalSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Cohort 5ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Cohort 6ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Cohort 7ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Cohort 8ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Cohort 9ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part B Optional Cohort 10ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo
Part C Optional Cohort 11ExperimentalSingle dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Receives: Drug: PF-07976016; Drug: Midazolam
Part C Optional Cohort 12ExperimentalSingle dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Receives: Drug: PF-07976016; Drug: Midazolam
Part D Optional Cohort 13ExperimentalMultiple dose administration of PF-07976016 or matching placebo.
Receives: Drug: PF-07976016; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses

    Measured: Day 1 up to approximately Day 36

  2. Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses

    Measured: Day 1 up to approximately Day 36

  3. Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses

    Measured: Day 1 up to approximately Day 36

  4. Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses

    Measured: Day 1 up to approximately Day 36

  5. Part B, Parts C and D, if conducted: Number of Participants With Treatment Emergent Adverse Events Following Multiple Doses

    Measured: Day 1 up to approximately Day 49

  6. Part B, Parts C and D, if conducted: Number of Participants With Clinical Laboratory Abnormalities Following Multiple Doses

    Measured: Day 1 up to approximately Day 49

  7. Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Multiple Doses

    Measured: Day 1 up to approximately Day 49

  8. Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Multiple Doses

    Measured: Day 1 up to approximately Day 49

Secondary outcomes (19)

  1. Part A: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration

    Measured: Day 1 up to Day 4

  2. Part A: Maximum Observed Plasma Concentration

    Measured: Day 1 up to Day 4

  3. Part A: Time to Reach Maximum Observed Plasma Concentration

    Measured: Day 1 up to Day 4

  4. Part A: Area Under the Curve From Time Zero to Extrapolated Infinite Time

    Measured: Day 1 up to Day 4

  5. Part A: Plasma Half-Life

    Measured: Day 1 up to Day 4

  6. Part B: Maximum Observed Plasma Concentration

    Measured: Days 1, 7 and 14

  7. Part B: Time to Reach Maximum Observed Plasma Concentration

    Measured: Days 1, 7 and 14

  8. Part B: Area Under the Curve From Time Zero to Time Tau

    Measured: Days 1, 7 and 14

  9. Part B: Plasma Half-Life

    Measured: Day 14

  10. Part B: Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau

    Measured: Day 14

  11. Part B: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau

    Measured: Day 14

  12. Part B: Renal Clearance of Drug

    Measured: Day 14

  13. Part C (if conducted): Maximum Observed Plasma Concentration of Midazolam

    Measured: Day 1, Day 3 and Day 11

  14. Part C (if conducted): Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration of Midazolam

    Measured: Day 1, Day 3 and Day 11

  15. Part C (if conducted): Area Under the Curve From Time Zero to Extrapolated Infinite Time of Midazolam

    Measured: Day 1, Day 3 and Day 11

  16. Part D (if conducted): Maximum Observed Plasma Concentration of PF-07976016

    Measured: Days 1 and 14

  17. Part D (if conducted): Time to Reach Maximum Observed Plasma Concentration of PF-07976016

    Measured: Days 1 and 14

  18. Part D (if conducted): Area Under the Curve From Time Zero to Time Tau of PF-07976016

    Measured: Days 1 and 14

  19. Part D (if conducted): Plasma Half-Life of PF-07976016

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start27 Oct 2023
  3. Primary completion19 Aug 2024
  4. Study completion19 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
Part A and B are randomized, double-blinded, sponsor-open, placebo-controlled studies to evaluate safety, tolerability, PK and PD of single and multiple escalating oral doses of PF-07976016 in healthy adult participants, respectively. Part A is a crossover while Part B is a parallel cohort study design. Part A of the study may also evaluate the safety, tolerability and PK in Japanese participants. Part C is an optional open-label, 4-period, fixed-sequence study to evaluate the effect of PF-07976016 on midazolam PK in healthy participants. Part D is an optional sponsor-open, randomized, double-blinded, placebo-controlled multiple dose study of PF-07976016 administered to participants with obesity.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106009
Sponsor's protocol ID
C5541001
Status last verified
Sep 2024
First submitted
24 Oct 2023
Last updated
23 Sep 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07976016 and Midazolam in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses (time frame: Day 1 up to approximately Day 36). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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Clinical Trial NCT06106009 | AzTrials